Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013756169

FEI Number

3013756169

Entity Name

GM DOS REIS INDUSTRIA E COMERCIO LTDA

City/State/Country

Campinas Sao Paulo, BR

Establishment Address

Avenida Pierre Simon de La Place, 600, Campinas Sao Paulo 13069320, BR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GM dos Reis Industria e Comercio Ltda (Owner Number: 10059832)

Owner / Operator Contact Address

Avenida Pierre Simon de La Place, 600, Campinas, BR-SP 13069320, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243740

PMA Number

N/A

All Registered Proprietary Names

TEMPLATE 354-100-050 - Meniscus Suture - OUT IN Minidriver Solaris Screw Removal Kit STA - ACHILLES TENDON SUTURE SYSTEM Suture Fisher Suture Passer Surgical instrument Tray, Surgical, Instrument Meniscus Versaflex 312-500 - MULTICUTTER - Arthroscopic Retrograde Drill 359-210 - ACCESS FIT RIGHT SUTURE PASSER 335-200 - MICRO EASYPASS - SMALL CURVED MICRO SUTURE PASSER 335-100 - MICRO EASYPASS - STRAIGHT MICRO SUTURE PASSER 335-99 - MICRO EASYPASS - SHORT CURVED MICRO SUTURE PASS 335-300 - MICRO EASYPASS - LARGE CURVED MICRO SUTURE PASSER 359-200 - ACCESS FIT STRAIGHT SUTURE PASSER 359-220 - ACCESS FIT LEFT SUTURE PASSER 335-600 - MICRO EASYPASS - EXTRA LARGE CURVED MICRO SUTURE PASSER Percutaneous Foot Burrs, GMREIS Arthodesis Burrs, GMREIS Orthopedic manual surgical instruments

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2024-11-04
HWT	Template	Orthopedic	Class 1	888.4800	2019-05-31
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2019-05-31
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2021-02-22
KIJ	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2026-02-18
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-03-30
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-03-30
HWB	Extractor	Orthopedic	Class 1	888.4540	2026-02-17
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-02-27
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2022-09-06
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-08-07
HWQ	Passer	Orthopedic	Class 1	888.4540	2024-06-07
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2022-08-29
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2019-05-31
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2026-02-27
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2023-04-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-01-18
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-01-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-06-28
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-06-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-11-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-11-26
HTT	Burr, Orthopedic	Orthopedic	Class 1	888.4540	2022-08-30
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-12-05
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2023-06-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-01-30
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-01-30

Official Correspondent

No official correspondent registered.

US Agent Details

PASSARINI CRO AND REGULATORY SOLUTIONS LLC Email: usagent@passarini.com.br Phone: (786) 8496760

Related Public Records

Same Entity

GM dos Reis Industria e Comercio Ltda

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3043620689	ORTOFACE COSMETICOS E PRODUTOS PARA SAUDE LTDA	Salto Sao Paulo, BR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K933337	R & D Batteries, Inc.	R AND D BATTERY REPLACEMENT	1994-04-05
K873766	Bowen & Company, Inc.	STERNAL POWER AWL	1988-11-14
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29
K190842	Jiangsu Trauhui Medical Instrument Co., Ltd.	Comus Locking Plate systems	2020-02-03
K130510	Arthrex, Inc.	ARTHREX COMPRESSION PLATES	2013-09-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013756169. Last updated year: 2026. Please use registration number 3013756169 when referencing this establishment in official correspondence.